Sr. Global Study Manager - Infectious Disease/Vaccines Pragmatic Trials - Canada or US Remote

Résumé du poste

Lead the operational execution of global clinical trials, managing the Clinical Trial Team, vendors, and budgets to ensure deliverables are met. Oversee trial set-up, recruitment planning, risk assessment, and inspection readiness for infectious disease and vaccine studies.

Détails du poste

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. Senior Study Manager May lead or support a study or studies, depending on size/complexity. As lead, will be responsible for the following: Operational point of contact for trial execution and all trial deliverables Manages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planning Manages deployment and interactions with external vendors (e.g., IVRS, PRO) Initiates planning for Investigator meeting and protocol training. Plans and assesses protocol ancillary supplies Completes trial set-up and maintains CTMS Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT Initiates recruitment/retention planning & enrollment tracking • Responsible for tracking study related details (e.g., specimens, queries) Oversees protocol training activities including IMs and CRAs training meetings Ensures appropriate postings to investigative site portals Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others) Point of escalation for study related operational issues Responsible for operational details at Operational Reviews Responsible for creating and maintaining project schedule and collaborating with Program Lead Sets up and maintains Trial Master File (eTMF) Ensures alignment of budget with protocol needs Responsible for executing protocol within the budget Responsible for creating and maintaining ADI logs Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group Develops study related manuals (e.g., administrative binder, lab manuals) Manages Emergency Unblinding (EUB) Call Center activities Co-authors newsletters with CS Approves contracts, invoice payments and change orders for vendors, as necessary Responsible for end of study reconciliation (clinical & ancillary supplies) Oversees all HQ close-out tasks Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking Supports CS activities as needed to achieve CTT deliverables Interface with External Data Coordination and Data Management Responsible for quality control and inspection readiness at all times Responsible for risk assessment, mitigation planning and execution What you need to have: BS/BA/MS/PhD with 7+ yrs clinical research experience Minimum Years of Experience Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required. Proven ability to meet aggressive timelines MS Project experience preferred Excellent Excel and PP skills required TA- Infectious disease and/or vaccines experience highly preferred Global experience required Excellent oral (including presentation) and written communication, computer/database management, and project management skills required Home Based position in US or Canada Areas of direct experience: Protocol design for pragmatic trials Site/site network selection Integration with healthcare systems Informed consent approaches (simplified, eConsent, etc.) Use of EHR / real-world data Endpoint definition (e.g., hospitalization, utilization) Central vs site monitoring approaches Vendor/technology integration Regulatory interactions / submissions Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply

Ce que vous ferez

Lead the operational execution of global clinical trials, managing the Clinical Trial Team, vendors, and budgets to ensure deliverables are met. Oversee trial set-up, recruitment planning, risk assessment, and inspection readiness for infectious disease and vaccine studies.

Exigences

Requires a degree with at least 7 years of clinical research experience, including 2 years of pharmaceutical leadership. Proficiency in MS Project, Excel, and experience with global infectious disease or vaccine trials is highly preferred.

Avantages

• Competitive Base Salary • Performance Related Incentives • Medical Coverage • Dental Coverage • Vision Coverage • Retirement And Pension Plans • Life Assurance • Disability Coverage • Employee Assistance Programmes • Wellbeing Resources • Learning And Development Opportunities

Compétences indiquées

• Microsoft Excel · Souhaitée
• Gestion de projet · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical Trial Management
• Project Management
• Infectious Disease Experience
• Vaccines Experience
• Pragmatic Trials
• Vendor Management
• Budget Management
• Risk Mitigation
• eTMF
• MS Project
• Excel
• PowerPoint
• Protocol Design
• Regulatory Submissions
• Site Monitoring
• Global Trial Execution

Domaines d’emploi

• Healthcare
• Science & Research
• Management & Leadership
• Consulting
• Manufacturing